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FDA Grants Approval

FDA Grants Approval

FDA Approval Alhemo as Once-Daily Prophylactic Treatment

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FDA Approves Alhemo as Once-Daily Prophylactic Treatment for Hemophilia A or B Without Inhibitors
Overview
On July 31, 2025, the U.S. Food and Drug Administration (FDA) approved Alhemo (concizumab-mtci) for the once-daily prophylactic treatment of adults and adolescents aged 12 years and older with hemophilia A or B without inhibitors. This marks a significant expansion of Alhemo’s indications. The medication was previously approved for patients with inhibitors to clotting factors VIII or IX in December 2024. With this new approval, Alhemo becomes a treatment option for a broader population of individuals living with inherited bleeding disorders.

FDA Grants Approval

US FDA Approves New Biktarvy Indication For People With HIV Who Are Treatment Experienced And Restarting Antiretroviral Treatment

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🗓 FDA Approval:
On July 30, 2025, the U.S. Food and Drug Administration approved a supplemental New Drug Application (sNDA) for Biktarvy (bictegravir 50 mg / emtricitabine 200 mg / tenofovir alafenamide 25 mg) to expand its indication. The drug may now be used in people with HIV (PWH) who have prior antiretroviral treatment, are not virologically suppressed, and are re‑starting ART, provided they have no known or suspected resistance to integrase strand inhibitors (INSTIs), emtricitabine, or tenofovir.

FDA Grants Approval

FDA Approves Ekterly

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FDA Approves Ekterly – Generic name: sebetralstat is a first-in-class oral, on-demand medication developed for the treatment of acute attacks in patients with hereditary angioedema (HAE) aged 12 years and older. It marks a significant advancement in HAE management, offering the first non-injectable option for immediate treatment of these potentially life-threatening swelling episodes.

FDA’s Advisory and Regulatory Actions
FDA Grants Approval

FDA Warns Consumers Against Inhaling Nitrous Oxide Products

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The U.S. Food and Drug Administration (FDA) has issued a strong warning advising consumers not to inhale nitrous oxide products due to serious health and safety risks. Commonly referred to as “laughing gas,” nitrous oxide is legally used for legitimate medical and industrial purposes, including as an anesthetic in dental procedures and as a propellant in whipped cream canisters. However, the FDA is raising the alarm about the growing trend of recreational use, particularly among young people, which can result in severe and sometimes irreversible consequences.

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